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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04446949
Other study ID # 68329
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2021
Est. completion date February 2028

Study information

Verified date June 2020
Source University of Oslo
Contact Frode Eick, M.Phil
Phone +4793853244
Email Frode.Eick@bymisjon.no
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Little research on the health service utilization and the health situation of undocumented pregnant migrants has been performed previously, and it is essential to obtain more information on the services given, and to examine whether residency status is a risk factor in maternal and perinatal health among migrants.This project will give new knowledge on undocumented women seeking care at the voluntary clinics and the emergency clinics (DEGPs) in Oslo and Bergen, their health care needs, and the medical follow-up they are provided. The project will present new knowledge by showing trends in undocumented pregnant migrants care seeking compared to general trends among other migrants and Norwegian residents. It will also give new knowledge on pregnancy outcomes and perinatal health in undocumented migrants compared to foreign and Norwegian born women. This approach has not previously been used to study undocumented migrants in Norway, and there are very few similar studies in other European countries. Cause and effect relations are rarely claimed in findings from observational epidemiologic studies, however the information from three different sources (voluntary clinics, emergency clinics and Medical Birth Registry) will give an overall picture of the use of primary health care in undocumented pregnant migrants, as well as a comparative assessment of maternal outcomes in this population. The proposed research will also give important knowledge on how to conduct quantitative research in a population that is difficult to reach, and that is not commonly included in research.


Description:

Research questions and objectives

1. Work package 1 (WP1): What characterizes pregnant undocumented migrants attending the voluntary clinics in Oslo and Bergen from 2009 to 2020?

1. Give a descriptive summary of the population of pregnant undocumented migrants seeking care (e.g. age, number of children, time stayed in Norway, work status, family network) and the medical problems they are presenting.

2. Investigate the care received based on indicators such as number of antenatal visits and the extent of collaboration with or referral to other health facilities.

3. Investigate the risk of pregnancy related complications (e.g. pre-eclampsia and gestational diabetes) and adverse perinatal outcomes (e.g. use of Caesarean Section and pre-term birth) in women seeking care at the clinics.

2. Work package 2 (WP2): Are there any consultation trends in pregnant undocumented migrants seeking emergency care at the emergency units (DEGPs) in Oslo and Bergen from 2007 to 2020?

1. Give a descriptive summary of the population of undocumented migrants seeking emergency care at the DEGPs, in particular pregnant undocumented migrants seeking care.

2. Investigate trends in emergency consultations at the DEGPs for pregnant undocumented migrants after the start of the voluntary clinics (2009/2014), comparing with the trends in consultations for the general population of pregnant women seeking care.

3. Investigate trends in emergency consultations at the DEGPs for pregnant undocumented migrants after the start of the voluntary clinics (2009/2014), comparing to the trends in consultations for other undocumented migrants.

3. Work package 3 (WP3): What is the occurrence of pregnancy-related complications and adverse perinatal outcomes (as reported in the Medical Birth Registry of Norway) in patients without national identity number from 1999 to 2020?

1. Investigate the prevalence of pregnancy related complications (e.g. pre-eclampsia, gestational diabetes, nutrient deficiency) in undocumented migrant women compared to foreign and Norwegian born women.

2. Investigate the incidence of adverse perinatal outcomes (e.g. use of Caesarean section, pre-term birth, small for gestational age, low Apgar score) in undocumented migrant women compared with foreign and Norwegian born women.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70000
Est. completion date February 2028
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- No registered Norwegian identity number

- Female

Exclusion Criteria:

- Male

Study Design


Intervention

Other:
Register follow-up
Number of adverse pregnancy outcomes

Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
University of Oslo Department of Emergency General Practice (DEGP) Oslo and Bergen, Norwegian Women's Public Health Association (NKS), Oslo Church City Mission, Red Cross

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse pregnancy outcomes From medical records and the Medical Birth Registry 1999-2020
Primary Primary health care use by undocumented pregnant migrants From voluntary clinics and emergency units 2007-2020
Secondary Health care use of undocumented migrants in general From voluntary clinics and emergency units 2007-2020
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